8 Hour Arthritis Pain

Product NDC
68998-401
11-digit product format
689980401
Labeler code
68998
Product ID
68998-401_092dc75a-fb8c-5f53-e063-6294a90adf6b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2022-10-05
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
8 Hour Arthritis Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68998-401-038 Hour Arthritis Pain1 in 1 CARTONTABLET, EXTENDED RELEASE13
68998-401-038 Hour Arthritis Pain100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-4018 HOUR ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [MARC GLASSMAN, INC.]3Current NDC, Legacy NDC, 2 package rows20231103_e2387b9c-94c0-397a-e053-2995a90a444c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNe2387b9c-94c0-397a-e053-2995a90a444c3
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDe2387b9c-94c0-397a-e053-2995a90a444c3
11483998 HR APAP 650 MG Extended Release Oral TabletSYe2387b9c-94c0-397a-e053-2995a90a444c3
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYe2387b9c-94c0-397a-e053-2995a90a444c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68998-401-03689980401031 BOTTLE, PLASTIC in 1 CARTON (68998-401-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2022-10-050000-00-00NoNoCurrent